Senior Production Engineer, Fractionation

Position Purpose:
The Senior Production Engineer provides technical leadership and strategic engineering support to pharmaceutical manufacturing operations ensuring optimal asset performance reliability and compliance throughout the asset lifecycle. This role drives risk-based asset management strategies
in alignment with ISO 55000 principles GMP requirements and business objectives while partnering with Production Maintenance Quality and Capital Projects teams.

Reporting Relationships:
Role that this position reports to:
Main Responsibilities and Accountabilities: List the roles and responsibilities of the position.

1) Process & Equipment Engineering
Provide senior-level frontline engineering support for complex equipment issues leading structured troubleshooting and failure investigations. Such as but not limited to separation extraction purification and filling processes.
Support fractionation bulk or fill finish systems including design operation and lifecycle management.
Provide engineering oversight for centrifuges filter presses chromatography
columns ultra-filtration and diafiltration clean-in-place clean out of place aseptic transfer technologies etc
Ensure robust GMP practices and contamination control throughout operations.
Lead Root Cause Analysis (RCA) using recognized methodologies (e.g. FMEA 5- Why Fishbone) and ensure effective implementation of CAPAs.
Define and drive equipment reliability strategies to improve availability
performance and lifecycle cost.

2) Maintenance & Asset Health Monitoring
Develop review and optimize preventive and predictive maintenance strategies based on asset criticality historical performance and condition monitoring data.
Analyze asset health using CMMS data (SAP) including MTBF MTTR OEE
contributors and maintenance effectiveness KPIs.
Champion predictive maintenance technologies and condition-based monitoring to reduce unplanned downtime and asset risk.

3) Change Management & Continuous Improvement
Lead equipment-related changes through formal change control processes and investigations ensuring GMP compliance data integrity and controlled risk.
Drive continuous improvement initiatives focused on asset reliability compliance and operational efficiency aligned with site and corporate asset management objectives.
Work to improve equipment reliability as measured by Operational Equipment
Effectiveness (OEE).
Mentor junior engineers and technicians in reliability engineering asset
management principles and GMP-compliant engineering practices.
Rotation between value streams
Provide technical training on aseptic equipment and best practices.

4) Asset Information & Lifecycle Management (ISO 55000 Alignment)
Own and govern asset information across the lifecycle ensuring integrity
traceability and alignment with ISO 55000 Asset Information Management
requirements including URS FS/DS P&IDs equipment files and SAP CMMS
records.
Lead asset criticality assessments and risk-based prioritization using failure
modes risk priority numbers (RPNs) and business impact analysis to support
maintenance and investment decisions.
Ensure alignment between asset performance objectives site asset management plans and production demand.

5) Projects & Shutdown Support
Lead equipment-related projects funded through Capital Expenditure (CapEx) or Operational Expenditure (OpEx) including scope definition business case
development risk assessment and execution.
Provide engineering leadership during planned shutdowns including scope
planning resource coordination execution oversight and post-shutdown
performance review.
Support equipment lifecycle decisions including refurbishment upgrade and
replacement strategies based on asset condition and business risk.

6) Compliance Quality & Safety
Ensure engineering activities comply with GMP EHS and ISO 55000/55001
requirements.
Author review and approve SOPs/ change controls deviations investigations and CAPAs.
Lead and support qualification and validation activities (IQ/OQ/PQ) ensuring
engineering documentation supports regulatory inspections and audits.
Act as a subject matter expert during internal and external audits related to
equipment asset management and reliability.

7) Completes any other duties/responsibilities assigned by senior management

Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position including educational experiential and competency requirements necessary for the position.

Education
Bachelors degree in Engineering (Mechanical Chemical Biomedical or
related field).
Masters degree in Engineering or related field preferred

Experience
5 years of engineering experience in pharmaceutical manufacturing.
Experience in Aseptic Bulk or Fractionation processing expertise
Technical problem-solving investigation and root cause analysis
Knowledge of Six Sigma/Lean principles is a plus.
Strong knowledge of sterile filling operations aseptic techniques and
contamination control.
Proven ability to successfully lead projects from start to finish ensuring
they are completed on time within budget and meet high standards of
quality.
Proven experience supporting cGMP environments and regulatory
inspections.
Knowledge of Six Sigma/Lean principles is a plus.

Competencies
Strategic Planning & Execution
Continuous Improvement & Lean/Six Sigma
Team Leadership & Development
Analytical Problem Solving
Stakeholder Engagement & Communication
Cross-functional collaboration

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

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